Suture winding device and methods of use thereof

ABSTRACT

A suture winding device is provided that includes a holder and a base having a needle holder for receiving a needle with a quantity of attached suture attached thereto. A plurality of rods is disposed on the base that may be arranged in one or more arrays. The plurality of rods at contribute to the alignment of a retainer disposed on the base that includes first and second members that may be joined together using pressure and/or heat. Prior to joining the first and second members of the retainer, the base may be rotated to form loops of suture around the arrays of rods.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/809,081, filed on May 31, 2007, which is a continuation-in-part ofU.S. patent application Ser. No. 11/373,366, filed Mar. 10, 2006, nowU.S. Pat. No. 7,322,161, which claims priority to U.S. ProvisionalPatent Application Ser. No. 60/661,184, filed Mar. 11, 2005. The entirecontents of each of these prior applications are incorporated byreference herein.

BACKGROUND

1. Technical Field

The present disclosure relates to devices and methods for packagingsutures and, more particularly, to a suture winding device and methodsfor use thereof.

2. Background of Related Art

Packages for surgical sutures having needles attached at one or bothends are typically constructed according to the nature of the suturematerial and to how the sutures will be used. Generally, the packageholds the suture and attached needles in place, protects them duringhandling and storage, and allows ready access to the suture for removalwith minimum handling at the time the suture is to be used.

The packages are loaded with one or more needles that have a desiredquantity of suture attached. After positioning the needle or needles inthe package, the attached suture is generally looped within the packageusing tracks, rods, posts, or other suitable positioning structureslocated within the package.

An example of one such package is disclosed in U.S. Pat. No. 5,123,528to Brown et al., currently owned and assigned to United States Surgical,that discloses a package having a number of tracks and a needlereceiving park. Each track has a suture receiving port and an opposedvacuum port. By applying vacuum to the vacuum receiving ports, aquantity of suture is drawn through the suture receiving port andreceived in the track. After a predetermined quantity of suture isreceived by the track, a needle attached to the suture is positioned inthe needle receiving park.

A device for winding a quantity of suture attached to a needle isdisclosed in U.S. Pat. No. 5,473,854 to Demarest et al. that disclosesan apparatus having a number of workstations for packaging needles withan attached suture. As a turntable of the apparatus rotates, a tool nestattached to the turntable is rotated from one workstation to the nextworkstation. Each workstation performs a specific task with respect topackaging the needle with attached suture.

SUMMARY

The present disclosure is directed to an apparatus for use with a suturepackage or retainer and one or more sutures. According to oneembodiment, the apparatus includes a base member, which may be rotatablymounted to a plate, a needle holder disposed within the base member, atleast one needle that is adapted for releasable engagement with theneedle holder and attached to a quantity of suture, a retainer packagedisposed atop the base member and including a first member having aplurality of throughholes, a plurality of rods configured in at leastone array that are engagable with, and correspond to, the throughholdes,and a holder having open and closed states. The holder is movablerelative to the base member between a first position and at least onesubsequent position, either manually or automatically, and includes afirst arm and a second arm. In the open state, the first and second armsare in spaced apart relation and in the closed state, at least a portionof the first arm is in substantial contact with at least a portion ofthe second arm.

The holder may slidably engage at least a portion of the suture in theclosed state such that a predetermined amount of tension may be appliedthereto.

The first member of the retainer may be adapted to receive the needle inthe needle holder and may additionally include a slot for receiving aportion of the suture.

In one aspect of the present disclosure, the rods of the at least onearray are movable from a retracted position to an extended position inwhich the rods are releasably engagable with the suture.

In another aspect of the present disclosure, rotation of the base membercorresponds to movement of the rods into the extended position such thatat least a portion of the suture is wound about the rods thereby forminga plurality of loops.

In yet another aspect of the present disclosure, the at least one arrayincludes a first array and at least one additional array. The rods ofthe first array and the at least one additional array are independentlyand sequentially movable from the retracted position to the extendedposition and are arranged in a first arc and at least one additionalarc. It is contemplated that the first arc may define a smaller radiusthan the at least one additional arc such that each of the plurality ofloops are in space apart relation and each define a diameter that islarger than that of the previous loop.

In another embodiment, an apparatus for packaging a suture is disclosedthat includes a base member having a first holder disposed therein, atleast one array disposed substantially along a longitudinal axis of thebase member and including at least one rod, a retainer package that hasat least a first member with at least one throughhole configured toreleasably receive the at least one rod of the at least one array, asecond holder that includes first and second arms, and a parkingmechanism having open and closed conditions. The second holder ismovably connected to the base member and is movable between a firstposition and at least one subsequent position.

In the open condition, the first and second arms of the parkingmechanism are in spaced apart relation, and in the closed condition, atleast a portion of the first arm is in substantial contact with at leasta portion of the second arm. The parking mechanism may be movablerelative to the base member between a first position and at least onesubsequent position. The present disclosure contemplates that theparking mechanism may be in the closed condition when the parkingmechanism is in the at least one subsequent position, and that in theclosed condition, the parking mechanism releasably retains at least aportion of the suture.

In yet another embodiment, the apparatus may also include at least onepositioning rod that is movable from a retracted position to an extendedposition in which the at least one positioning rod is engagable with atleast a portion of the suture. In still another embodiment, the at leastone positioning rod is in the extended position when the parkingmechanism is in the at least one subsequent position such that at leasta portion of the suture is disposed within the parking device and aboutthe positioning rod.

At least a portion of the suture may form an angle with respect to anaxis of the base member that is in the range of approximately 0° toapproximately 180°.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the presently disclosed suture winding device aredescribed herein with reference to the drawings, wherein:

FIG. 1 is a perspective view of one embodiment of the presentlydisclosed suture winding device with an embodiment of a holder;

FIG. 2 is a perspective view of the suture winding device of FIG. 1including a mounting member;

FIG. 3 is a side elevational view of the holder of FIG. 1 in a firststate;

FIG. 4 is a side elevational view of the holder of FIG. 3 in a secondstate;

FIG. 5 is a perspective view of the suture winding device of FIG. 1 witha pair of needles having a length of suture disposed in a needle holderand the holder being in a loading position;

FIG. 6 is a perspective view of the suture winding device of FIG. 5 witha first member of a retainer positioned thereon;

FIG. 6A is a perspective view of an alternate embodiment of the suturewinding device of FIG. 5;

FIG. 7 is a perspective view of the suture winding device of FIG. 6 withthe holder being in an unloading position;

FIG. 8 is a perspective view of the suture winding device of FIG. 7 witha second member of the retainer positioned atop the first member of theretainer;

FIG. 9 is a perspective view of the suture winding device of FIG. 8 anda heat staking apparatus;

FIG. 10 is a perspective view of the suture winding device and the heatstaking apparatus of FIG. 9 with a die plate positioned atop theretainer;

FIG. 11 is a perspective view of the suture winding device and the heatstaking apparatus of FIG. 10 after assembly of the retainer;

FIG. 12A is a perspective view of another embodiment of the suturewinding device and the heat staking apparatus of FIG. 10 including aparking mechanism in a first position;

FIG. 12B is a perspective view of the suture winding device of FIG. 12Ain a subsequent position;

FIG. 13A is a side perspective view of the parking mechanism of FIGS.12A-12B showing the parking mechanism in an open condition;

FIG. 13B is a side perspective view of the parking mechanism of FIGS.12A-12B showing the parking mechanism in a closed condition;

FIG. 14A is a perspective view of another embodiment of the presentlydisclosed suture winding device with an embodiment of the holder in theloading position and a first array of rods in a second position;

FIG. 14B is a perspective view of the suture winding device of FIG. 14Ashowing a second array of rods in the second position;

FIG. 14C is a perspective view of the suture winding device of FIG. 14Bshowing a third array of rods in the second position and the holder inthe unloading position;

FIG. 15 is a perspective view of the presently disclosed suture windingdevice and another embodiment of a holder shown in a loading position;

FIG. 16 is a perspective view of the suture winding device and holder ofFIG. 15 shown in an unloading position; and

FIG. 17 is an exploded perspective view of an embodiment of theretainer.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Embodiments of the presently disclosed suture winding device will now bedescribed in detail with reference to the drawings, in which likereference numerals designate identical or corresponding elements in eachof the several views.

Referring initially to FIG. 1, the suture winding device, showngenerally as 100, includes a base 10 that is rotatably attached to asupport plate 1 and is rotatable about a central point A.

As shown in FIGS. 1 and 2, base 10 includes a frame 18 and a plate 19that is attached to a mounting surface 26 of frame 18. In an embodimentof suture winding device 100, frame 18, and plate 19 have a generallyoval or elongate elliptical configuration. Other shapes may also be usedand are contemplated herein. Base 10 further includes a plurality ofvacuum connections 12 where each vacuum connection includes a vacuumport 12 a. Each vacuum connection 12 is fluidly coupled to a vacuumsource (not shown) such as would be known by a person of ordinary skillin the art. The actuation of vacuum connections 12 (i.e. applyingnegative pressure or suction to vacuum ports 12 a) may be controlledmanually or automatically.

In addition to vacuum connections 12, a plurality of rods 22 is arrangedon plate 19 and at least a portion of each rod 22 extends through topsurface 24. Each rod 22 includes a tip 23 that is configured anddimensioned to extend beyond a top surface of a mounting member 7 (FIG.2). In one embodiment, rods 22 include interior rods 22 a and exteriorrods 22 b. In suture winding device 100, the plurality of rods 22 may bearranged to form a first array 20 a and a second array 20 b. In oneembodiment of suture winding device 100, first array 20 a and secondarray 20 b are generally arcuate arrangements of exterior rods 22 b thatare spaced apart along a longitudinal axis of base 10.

A needle holder 50 is disposed in a central region of mounting member 7(FIG. 2) and separates first array 20 a from second array 20 b. Mountingmember 7 is disposed on base 10 such that it abuts top surface 24.Needle holder 50 is releasably disposed in mounting member 7 andincludes a plate 52 having a plurality of buttons 54 disposed thereon.In an embodiment of suture winding device 100, buttons 54 are arrangedin pairs to form one or more needle channels 64. Each needle channel 64is configured and adapted for releasably engaging a needle 14 (FIG. 5).Needle 14, as is known in the art, has a sharpened tip at one end and alength of suture 16 extending from an opposing end. Disposed on one endof plate 52 are a post 56, a needle guide 58, and an end member 60. Post56 and end member 60 are spaced apart to form a suture channel 62therebetween. Needle guide 58 in cooperation with buttons 54 positionneedle 14 in needle holder 50 such that suture 16 is releasably receivedin suture channel 62 (FIG. 5). In one embodiment, suture 16 ispositioned on mounting member 7 such that it contacts at least oneinterior rod 22 a (FIG. 5). Needle holder 50 may be replaced byalternate embodiments of the needle holder that are configured toreceive single needles, double needles, or needles of varying diametersand dimensions regardless of whether the needles are in a single ordouble configuration.

A suture package or retainer 70 (FIG. 17) is positionable on base 10 asillustrated in FIGS. 6-8 and 15. A suitable retainer 70 is the subjectmatter of U.S. patent application Ser. No. 10/891,604 filed on Jul. 15,2004, currently owned and assigned to Tyco Healthcare Group, thecontents of which are hereby incorporated by reference in theirentirety. Referring now to FIG. 17, retainer 70 includes a first member72 and a second member 74. Second member 74 is adapted to attach tofirst member 72 as will be discussed in further detail below.

With reference to FIG. 6, first member 72 is shown disposed on mountingmember 7 of base 10. In one embodiment, the position of first member 72with respect to mounting member 7 is maintained by vacuum connections 12(FIG. 1) that are disposed in base 10. More specifically, vacuum appliedthrough vacuum connections 12 holds first member 72 to vacuum ports 12a. First member 72 is disposed on top of mounting member 7. Positionedbetween first member 72 and mounting member 7 is needle 14 with a lengthof suture 16 attached thereto. First member 72 includes a plurality ofthroughholes 76 arranged to correspond with rods 22 (FIG. 1) of base 10thereby aligning needle holder 50 with a needle park or needle grip 80of first member 72. As shown in FIG. 17, first member 72 includes needlepark 80 for releasably attaching needle 14 to first member 72. Needlepark 80 is positioned on first member 72 such that is aligned withneedle holder 50 when first member 72 is positioned on plate 19 by thecooperative arrangement of rods 22 and throughholes 76. As with needleholder 50, needle park 80 may be replaced by alternate embodiments thatare configured to receive single needles, double needles, or needles ofvarying diameters and dimensions regardless of whether the needles arein a single or double configuration.

Needle park 80 includes a number of tabs 82 and notches 84 that extendfrom a surface of first member 72 towards plate 19. In one embodiment,needle holder 80 is disposed in a recess 86 on an underside of firstmember 72. Each tab 82 and its corresponding notch 84 are configured andadapted for releasably gripping needle 14 such that when retainer 70 isremoved from base 10, needle 14 separates from needle holder 50 and isreleasably attached to retainer 70 by needle park 80. Tabs 82 andnotches 84 are biased towards each other for releasably receiving needle14. A slot 78 is disposed along an edge of first member 72 where slot 78communicates with recess 86 such that a portion of suture 16 may extendthrough recess 86 and be accessed from outside retainer 70.

Transfer of needle 14 from needle holder 50 to needle park 80 isaffected by forces applied by an operator in a generally downwarddirection (i.e. towards plate 19) on first member 72. As first member 72is urged towards plate 19 and needle holder 50, needle 14 contactsneedle park 80 with sufficient force to overcome the bias of tab 82 andnotches 84. By overcoming the bias of tabs 82 and notches 84, the spacebetween tab 82 and notches 84 is sufficient to receive needle 14. Afterfirst member 72 has moved a predetermined distance, needle 14 no longerurges tab 82 and notches 84 away from each other whereupon the bias oftab 82 and notches 84 act to urge them towards each other for releasablyretaining needle 14. In configurations including more than one needle14, each set of tab 82 and notches 84 is configured as previouslydescribed. Alternatively, vacuum applied to first member 72 throughvacuum ports 12 a may supply the forces that urge needle 14 intoreleasable engagement with needle park 80 as previously discussed. Inanother embodiment, a combination of applied vacuum and operator actionsupply the forces for urging needle 14 into releasable engagement withneedle park 80.

Base 10 is rotatable such that suture 16 contacts each exterior rod 22 bsequentially. As base 10 completes each rotation, a loop of suture 16 isformed about exterior rods 22 b. A predetermined amount of tension ismaintained on suture 16 by a holder 30. Holder 30 is mounted to supportplate 1 and is rotatable with respect to base 10. In one embodiment,holder 30 is rotatable amongst a plurality of positions including aloading position (FIG. 1) and an unloading position (FIG. 7). Inaddition, holder 30 is rotatable amongst the plurality of positionswhile base 10 is rotating about the central point (i.e. base 10 andholder 30 are independently positionable).

More specifically, holder 30 is attached to a mounting arm 42 (FIG. 1)that is rotatably attached to plate 1 and is capable of being positionedin at least the loading position and the unloading position of holder 30and, preferably may be positioned in any position therebetween. Furtherstill, mounting arm 42 is capable of being positioned independently ofbase 10.

In a further embodiment, as seen in FIG. 6A, a suture winding device 90includes a holder 92 that is rotatably attached to a plate 94 andmovable through a plurality of positions, e.g. loading and unloadingpositions, as discussed above with respect to the embodiment depicted inFIGS. 1-7. In this embodiment, suture winding device 90 includes aprogrammable control module, actuator, or the like, generally designatedby reference numeral 96, that is operatively connected to holder 92 suchthat movement through the plurality of positions may be either manuallyor automatically regulated.

Referring again to FIG. 6, in the loading position, holder 30 orientssuture 16 such that a desired angle between suture 16 and base 10 isachieved. In the unloading position, holder 30 orients suture 16 suchthat it is substantially parallel to the longitudinal axis of base 10.The predetermined amount of tension applied to suture 16 is maintainedby holder 30 regardless of its position relative to base 10 or whetheror not base 10 is being rotated.

In particular and with reference to FIGS. 3 and 4, holder 30 includes afirst arm 32 and a second arm 34. First arm 32 is movable such thatholder 30 may transition between an open state and a closed state whilesecond arm 34 is stationary. In particular, second arm 34 is fixedlyattached to a block 48 that is, in turn, fixedly attached to a mountingblock 47 that is attached to a wall 40.

Mounting block 47 includes an actuator and a slot 38 therein. Slot 38 isconfigured and dimensioned for slidably receiving a driver arm 36. Firstarm 32 is attached to driver arm 36 such that movement of driver arm 36results in corresponding movement of first arm 32. In one embodiment,driver arm 36 is movable in slot 38 in a substantially verticaldirection. In the open state, first arm 32 is spaced apart from secondarm 34 defining a gap 45 therebetween (FIG. 3). Gap 45 has sufficientdimensions such that suture 16 may be fed through gap 45 withoutcontacting either first or second arms 32, 34.

First arm 32 is moved towards second arm 34 during an actuation sequencesuch that first arm 32 substantially abuts second arm 34. In oneembodiment, first and second arms 32, 34 may include respective firstand second cushioning members 32 a, 34 a. During an actuation sequence,a pressure source is fluidly coupled to actuation ports 46 to providethe motive force to operate the actuator. Known pressure sources such aspneumatics (e.g. air, compressed gases, vacuum) or hydraulics (e.g.water, saline, oil) may be used with the actuator. In anotherembodiment, the actuator may be electrically powered by either AC or DCsources. Pneumatic, hydraulic, or electric actuators are well known toone skilled in this art and will not be discussed in detail herein.

Upon actuation, the actuator imparts motion to driver arm 36 to movedriver arm 36 generally downward thereby transitioning it from its openstate to its closed state. In the closed state, first arm 32 abutssecond arm 34 and for slidably capturing a section of suture 16therebetween. The amount of force exerted on suture 16 by first andsecond arms 32, 34 in the closed state is adjustable such that theamount of pressure applied is sufficient to allow suture 16 to be fedfrom a source to form the loops as base 10 rotates while maintaining thedesired amount of tension on suture 16. Additionally, the amount ofpressure applied by first and second arms 32, 34 minimizes drooping of alength of suture 16 extending between holder 30 and first member 72 whenbase 10 is stationary. By providing holder 30 to supply a predeterminedamount of tension to suture 16 during the winding process, suture 16 isdisposed within retainer 70 with a substantially uniform amount ofapplied tension. Additionally, holder 30, in cooperation with a uniformarrangement of rods 22, supplies the desired amount of tension to suture16 during the winding process thereby distributing suture 16 in retainer70 in a substantially uniform arrangement.

In an alternate embodiment, one or both of the first and second arms ofthe holder are movable relative to each other. In this embodiment, asthe holder transitions from the open state to the closed state, thefirst arm may move toward the second arm, the second arm may move towardthe first arm, or both arms may move towards each other. A programmablecontrol module, actuator, or the like, may be operatively connected toone or both of the first and second arms of the holder such that theapproximation thereof may be manually or automatically regulated.

Referring still to FIGS. 3 and 4, after the desired number of loops areformed (i.e. the desired quantity of suture 16 is disposed on firstmember 72 of retainer 70), rotation of base 10 is halted. Holder 30 ismoved from the loading position to the unloading position while stillmaintaining the desired tension on suture 16. When holder 30 is in theunloading position, second member 74 is placed on top of first member72, thereby forming retainer 70 and securing needle 14 and attachedsuture 16 within retainer 70. First arm 32 then transitions to its openstate thereby releasing suture 16. Suture 16 is then separated from itssource by known techniques such as cutting and a free end of suture 16is positioned along a surface of first member 72. Alternatively, suture16 may be separated from its source prior to transitioning first arm 32to its open state. Throughholes 76 in second member 74 are arranged tocorrespond with and slidingly receive rods 22 thereby aligning first andsecond members 72, 74.

In one embodiment, first and second members 72, 74 are press fittogether using applied pressure to engage corresponding edge portions ofrespective first and second members 72, 74 as is known in the art. Inanother embodiment, first and second members 72, 74 are joined togetherusing a heat stake 110, such as those known in the art and illustratedin FIG. 9. Heat stake 110 includes a die plate 112 that is positionablealong a vertical axis of heat stake 110. After retainer 70 is assembled(i.e. second member 74 is placed on top of first member 72), base 10 andretainer 70 are positioned such that die plate 112 is in substantialvertical alignment with retainer 70 by moving plate 1 along a horizontalset of rails or guides 122 that are mounted on plate 120. Plate 1,including base 10, is slidably attached to rails 122 using structuresthat are known in the art. In the alternative, base 10 may be stationaryand heat stake 110 may be positionable along a horizontal set of railsor guides towards or away from base 10.

Once die plate 112 and base 10, particularly retainer 70, are verticallyaligned (FIG. 10), one or both of base 10 or heat stake 110 is locked inposition thereby maintaining the vertical alignment between retainer 70and die plate 112. Die plate 112 includes at least one heating elementas is known in the art such that when die plate 112 contacts secondmember 74 with a desired amount of pressure, a combination of thedesired amount of pressure and/or thermal energy from the heatingelement joins first and second members 72, 74 to form retainer 70 (FIG.10). In addition, die plate 112 includes a plurality of channels ortubes (not shown) configured and arranged for slidably receiving rods22. After first and second members 72, 74 are joined to form retainer70, die plate 112 separates from base 10 (FIG. 11) allowing movement ofplate 1 and removal of retainer 70 from base 10.

A method of winding a needle or an armed needle using the hereinabovedescribed suture winding device 100 will now be discussed in detail.With reference initially to FIG. 5, one or more needles 14 having aquantity of suture 16 attached thereto is positioned in needle holder50. Specifically, each needle 14 is positioned in a separate needlechannel 64 and attached suture 16 is threaded between interior rods 22 aand exterior rods 22 b such that suture 16 is positioned between atleast one interior rod 22 a and at least one exterior rod 22 b. Afterthreading suture 16 between interior and exterior rods 22 a, 22 b,suture 16 extends beyond a top surface of mounting member 7. Firstmember 72 of retainer 70 is placed on mounting member 7 such that rods22 align with throughholes 76. Since rods 22 and throughholes 76 areconfigured for slidably engaging one another, a minimum amount ofdownward force is applied to position first member 72 in contact withthe top surface of mounting member 7. Suture 16 extends through slot 78of first member 72 and is accessible from a region exterior to base 10.

Once first member 72 of retainer 70 is positioned on mounting member 7,vacuum may be applied through vacuum ports 12 a thereby holding firstmember 72 in substantial contact with the top surface of mounting member7. Suture 16 is placed between first and second arms 32, 34 of holder 30while first arm 32 is in the open state (FIG. 3). After placing suture16 between first and second arms 32, 34, the actuator is energized bythe selected power source (i.e. pneumatic, hydraulic, or electric) totransition first arm 34 from the open state to the closed state andslidably capturing a portion of suture 16 therebetween.

Base 10 is rotated as suture 16 is fed from a source (not shown) therebywinding a quantity of suture 16 around rods 22 forming loops of suture16. After a desired quantity of suture 16 is disposed on first member72, rotation of base 10 is halted. Holder 30 is then positioned from itsloading position shown in FIG. 6 to its unloading position in FIG. 7. Bymaintaining suture 16 between arms 32 and 34 of holder 30 as ittransitions from its loading position to its unloading position, adesired amount of tension is maintained on suture 16 prior to joiningfirst and second members 72, 74 of retainer 70. The desired quantity ofsuture 16 that is disposed on first member 72 may then be separated fromthe source of suture 16 by cutting or other techniques known in the art.The separated end of suture 16 is positioned along the top surface offirst member 72 prior to placing second member 74 atop first member 72.

After second member 74 is positioned on top of first member 72, pressureand/or heat may be used to form retainer 70 by joining first and secondmembers 72, 74. As seen in FIG. 9, the assembled retainer 70 sits atopbase 10 and plate 1. Plate 1 may be moved along rails 122 forpositioning plate 1 and base 10 in alignment with die plate 112 suchthat vertical movement of die plate 112 will contact second member 74 ofretainer 70 to apply a desired amount of pressure and/or thermal energyto join first and second members 72, 74 (FIG. 10). Channels (not shown)in die plate 112 slidably receive rods 22 as die plate 112 contactssecond member 74. After joining first and second members 72, 74, dieplate 112 is moved away from base 10 in a generally vertical direction(FIG. 11) such that base 10 and retainer 70 may be moved along rails122. Retainer 70 is now formed and includes needle 14 and the desiredquantity of suture 16. The steps are repeatable for each retainer 70 tobe formed.

Referring now to FIGS. 12A-13B, in another embodiment, an apparatus 200for packaging a suture 216 includes a base member 210, at least one rod222 arranged in at least one array 220, a retainer package 270, and aholder 230 having first and second arms (not shown). Each of theseelements is substantially similar to those described above with respectto the previous embodiments and have been renumbered accordingly. Forthe sake of brevity, only the differences between the embodiments willbe discussed in detail. In this embodiment, apparatus 200 furtherincludes a parking mechanism 240 and at least one positioning rod 260.

Parking mechanism 240 maintains a pre-determined orientation of a tailportion 216 a of suture 216 during the winding process, as discussed infurther detail below, and includes an attachment member 242 and firstand second arms 244, 246, respectively.

Attachment member 242 is any plate, strut, rod, or other structuresuitable for the intended purpose of associating parking mechanism 240with apparatus 200. In the embodiment depicted in FIGS. 12A-12B,attachment member 242 is fixedly supported on a heat stake apparatus 280similar to that which was discussed above with respect to the embodimentdepicted in FIGS. 9-11. The attachment member 242 may be movablysupported on the heat stake apparatus 280. Additionally, the attachmentmember 242 may be either fixedly or movably supported to the apparatus200 itself at any suitable location, e.g. the base member 210, or to anyother structure suitable for the intended purpose of facilitating theoperation of the parking mechanism 240, as described in further detailbelow.

Referring still to FIGS. 12-12B, second arm 246 is movably connected toattachment member 242 such that parking mechanism 240 is free to pivot,rotate, slide, or the like, between a first position (FIG. 12A) and atleast one subsequent position (FIG. 12B). Movement of parking mechanism240 between the first position and the at least one subsequent positionmay be facilitated through any suitable structural mechanism, e.g., ahinge or a pivot.

In the first position (FIG. 12A), parking mechanism 240 is oriented soas not to engage suture 216. In the at least one subsequent position(FIG. 12B), parking mechanism 240 is reconfigured to facilitateengagement with at least a portion, e.g. tail portion 216 a, of suture216, as described in further detail below. The parking mechanism may beoperatively associated with a programmable control module, actuator, orthe like, such that movement from the first position to the at least onesubsequent position may be manually or automatically regulated.

Alternatively, the attachment member may be fixedly attached to theapparatus such that the radial, lateral, or rotational movement of theparking mechanism is substantially prevented. As such, the parkingmechanism remains substantially stationary and, accordingly, does nottransition between the first and second positions discussed above.

Parking mechanism 240 includes respective first and second arms 244,246. In one embodiment, first arm 244 is movable in relation to secondarm 246 such that parking mechanism 240 may transition between an opencondition (FIG. 13A) and a closed condition (FIG. 13B), while second arm246 is stationary.

Second arm 246 includes a slot 248 defined therein that is configuredand dimensioned to slidably receive a portion of first arm 244. In theopen condition, first arm 244 is spaced apart from second arm 246 suchthat a space 250 is defined therebetween that is dimensioned to receiveat least a portion of suture 216, e.g. tail portion 216 a. First arm 244is approximated relative to second arm 246 during an actuation sequenceuntil first arm 244 substantially abuts second arm 246, thereby closingoff space 250 in the closed condition, and releasably retaining tailportion 216 a of suture 216 therein.

In another embodiment, the parking mechanism may be operativelyconnected to a programmable control module, actuator, or the like suchthat the transition from the open condition to the closed condition maybe manually or automatically regulated.

As seen in FIGS. 12B and 13B, when parking mechanism 240 is in thesecond position and the closed condition, tail portion 216 a of suture216 in oriented and maintained in desired, pre-determined manner withrespect to base member x defined by angle Φ, as discussed in furtherdetail below. Angle Φ may be any angle substantially within the range of0° to 180°.

In one embodiment, the present disclosure contemplates that both thefirst and second arms of the parking mechanism are movable. As theparking mechanism transitions from the open condition to the closedcondition, the first and second arms approximate relative to oneanother.

As indicated above, apparatus 200 also includes at least one positioningrod 260 that is extendable at least partially through an aperture 212formed in base member 210 and retainer package 270. Positioning rod 260includes a tip 262 and is movable from a first or retracted position,seen in FIG. 12A, in which tip 262 is substantially flush with or belowbase member 210, to a second or extended position, seen in FIG. 12B, inwhich positioning rod 260 is configured to engage tail portion 216 a ofsuture 216. In the extended position, positioning rod 260 ensures thattail portion 216 a remains in the predetermined orientation, asdiscussed above, until assembly of the retainer package 270 is complete.In one aspect of the present disclosure, the parking mechanism and thepositioning rod cooperate to orient the tail portion of the suturewithin a perimeter of the retainer package.

The positioning rods may be operatively connected to a programmablecontrol module, actuator, or the like, such that the transition of thepositioning rod between the first or retracted position and the secondor extended position may be either manually or automatically regulated.

A method of winding a suture 216 using apparatus 200 will be discussed.Prior to the formation of loops “L” of suture 216 about rods 222, themethod described hereinbelow is substantially identical to that whichwas discussed above, and will therefore not be repeated. During andimmediately prior to the formation of loops “L”, parking mechanism 240is in the first position (FIG. 12A) and in the open condition (FIG.12B). Subsequent to the formation of loops “L”, parking mechanism 240transitions both into the second position (FIG. 12B), so at tofacilitate engagement with tail portion 216 a of suture 216, and theclosed condition (FIG. 13B), thereby releasably capturing tail portion216 a within space 250.

After positioning parking mechanism 240 in the second position and theclosed condition, positioning rod 260 is extended from the retractedposition (FIG. 12A), such that tip 262 extends at least partially beyondbase 210, thereby facilitating engagement of positioning rod 260 withtail portion 216 a of suture 216. In the extended position, positioningrod 260 cooperates with parking mechanism 240 to configure tail portion216 a of suture 216 in the pre-determined orientation, as discussedabove.

Referring now to FIGS. 14A-14C, another embodiment of the suture windingdevice is illustrated and shown generally as 300. Suture winding device300 includes a base 310 that is rotatably mounted to a plate 301. Holder30, that was discussed in detail previously with reference to FIGS. 3-4,is rotatably mounted to plate 301. Base 310 is a generally ellipticalstructure that includes a frame 318 and a plate 319 that is attached toa mounting surface 326 of frame 318. A mounting member 307 is disposedatop plate 319 and provides a surface suitable for positioning a firstmember 372 of a retainer. Mounting member 307 includes needle holder 50as previously shown and described with reference to FIG. 2. As in theprevious embodiment, needle 14 has a quantity of suture 16 attachedthereto and is disposed in needle holder 50. A portion of suture 16extends beyond base 310 and is threaded through first and second arms32, 34 of holder 30.

Suture winding device 300 includes a plurality of rods 322 that isextendable through throughholes 376 of first member 372 where each rod322 includes a tip 323. In this embodiment, rods 322 are positionablebetween a first or retracted position and a second or extended positionas shown in FIGS. 14A-14C. It is contemplated that the suture windingdevice may include a programmable control module, an actuator, or thelike, operatively connected to the rods such that the transition betweenthe first or retracted position and the second or extended position maybe either manually or automatically regulated. When in the extendedposition, rods 322 are capable of forming one or more loops of suture 16as will be discussed in detail hereinbelow. In the retracted position,tips 323 of rods 322 are substantially flush with a top surface ofmounting member 307. Alternatively, tips 323 may exist below the topsurface of mounting member 307. In addition, rods 322 are arranged inone or more arrays 330. Each array 330 includes a plurality of rods 322that are arranged in one or more arcs 340 of rods 322. Furthermore, inan embodiment having two arrays 330, the arrays 330 are spaced apartalong a longitudinal axis of base 310. Similar to suture winding device300, arrays 330 are spaced apart about needle holder 50. Needle holder50 is releasably mounted in mounting member 307 such that a top surfaceof plate 52 is substantially flush with the top surface of mountingmember 307. As in the previous embodiment, needle holder 50 may bereplaced by alternate embodiments of the needle holder that areconfigured to receive single needles, double needles, or needles ofvarying diameters and dimensions regardless of whether the needles arein a single or double configuration.

In FIG. 14A, rods 322 are shown in the extended position and each array330 includes an arc 340 of rods 322. Additional arcs 340 are illustratedin FIGS. 14B-14C. In FIG. 14B, each array 330 includes two arcs (340 a,340 b) while FIG. 14C illustrates suture winding device 300 with threearcs (340 a, 340 b, 340 c) in each array 330. The spatial arrangementand relationship of rods 322, arrays 330, and arcs 340 will now bediscussed in further detail. Moving from needle holder 50 towards anouter edge of mounting member 307, arcs 340 have successively largerradii such that rods 322 in arc 340 a (i.e. closest to needle holder 50)are spaced closer together than rods 322 in arc 340 b (FIG. 14B). In anembodiment including three arcs (FIG. 14C), arc 340 c is spaced furtheraway from needle holder 50 than arc 340 b and has a larger radii thanarc 340 b or 340 a such that rods 322 in arc 340 c are spaced furtherapart than rods 322 in arc 340 a or 340 b. In addition, inconfigurations using more than three arcs, the radius of each arcincreases as each arc is spaced further away from needle holder 50towards the outer edge of mounting member 307 thereby increasing thedistance between rods 322 in each arc.

As previously mentioned, rods 322 are positionable between a retractedposition and an extended position. Each rod 322 may be independentlypositionable. In one embodiment, rods 322 in each arc (340 a, 340 b, or340 c) are positionable as a group such that all rods 322 in each arc(340 a, 340 b, or 340 c) move substantially simultaneously. In addition,in embodiments having two arrays 330, arcs may be positionedsequentially such that rods 322 in arc 340 a are moved substantially inunison from the retracted state to the extended state or vice versa.Furthermore, additional arcs 340 b, 340 c are positioned similarly suchthat corresponding arcs in each array 330 (i.e. arc pairs 340 a, 340 aor 340 b, 340 b or 340 c, 340 c) are moved substantially simultaneously.

Operative force to transition rods 322 from the retracted to theextended position or the extended to the retracted position may besupplied by mechanical, hydraulic, pneumatic, or electric sources as arewell known to those of skill in the art. In one embodiment, rods 322 aretransitioned from their positions using a number of cams and/or levers.Alternately, hydraulic force supplied by water or oil, pneumatic forcesupplied by air or other compressed gasses, or electric force suppliedby motors or solenoids may be substituted for or combined with the camsand/or levers.

A method of winding a needle or an armed needle using the hereinabovedescribed suture winding device 300 will now be discussed in detail.With reference initially to FIG. 14A, each array 330 has rods 322 of arc340 a in their extended position. One or more needles 14 having aquantity of suture 16 attached thereto is positioned in needle holder 50as discussed in detail above with reference to FIG. 5 and first member372 is placed on mounting member 307 such that rods 322 in the extendedposition align with throughholes 376. Since rods 322 and throughholes376 are configured for slidably engaging one another, a slight amount ofdownward force is required to position first member 372 in contact withthe top surface of mounting member 307. Suture 16 extends through slot378 of first member 372 such that it is accessible from an outsideregion. Subsequently, suture 16 is positioned such that a portion ofsuture 16 contacts one or more of rods 322 in arc 340 a.

Suture 16 is then placed between first and second arms 32, 34 of holder30 while first arm 32 is in the first state (FIG. 3). After placingsuture 16 between first and second arms 32, 34, the actuator isenergized by the selected power source (i.e. pneumatic, hydraulic, orelectric) to transition first arm 34 from the first state to the secondstate (i.e. towards second arm 34) and slidably capturing a portion ofsuture 16 therebetween.

Base 310 is rotated on plate 301 such that a desired quantity of suture16 is wound about rods 322 in arcs 340 a forming loops of suture 16(FIG. 14A). After one or more loops are formed about arcs 340 a, rods322 in arcs 340 b may be transitioned to their extended position (FIG.14B) while base 310 continues to rotate on plate 301 and rods 322 inarcs 340 a remain in their extended position. Once rods 322 of arcs 340b are transitioned to their extended positions, suture 16 now formsloops only about arcs 340 b without forming additional loops about arcs340 a. After one or more loops of suture 16 are formed about arcs 340 b,rods 322 in arcs 340 c may be transitioned to their extended position(FIG. 14C) while base 310 continues to rotate. As base 310 rotates, oneor more loops of suture 16 are only formed about arcs 340 c withoutforming additional loops about arcs 340 a or 340 b. While loops ofsuture 16 are forming about arcs 340 c, rods 322 in arcs 340 a and 340 bremain in their extended position maintaining the previously formedloops of suture 16.

After a desired quantity of suture 16 is disposed on first member 72,rotation of base 310 is halted. Holder 30 is then positioned from itsloading position shown in FIG. 14A to its unloading position in FIG.14C. By maintaining suture 16 between arms 32 and 34 of holder 30 as ittransitions from its loading position to its unloading position, adesired amount of tension is maintained on suture 16 prior to formingretainer 70. The desired quantity of suture 16 that is disposed on firstmember 372 may then be separated from the source of suture 16 by cuttingor other techniques known in the art. The separated end of suture 16 ispositioned along the top surface of first member 372 prior to placing asecond member of retainer atop first member 372 similar to the formationof retainer 70 in the previously discussed embodiment.

Joinder and formation of retainer 70 is substantially similar to that ofthe previous embodiment using pressure and/or thermal energy from heatstake apparatus 110 as illustrated in FIGS. 9-11 and discussedpreviously.

In another embodiment, holder 30 is attached to a rail assembly 400 asshown in FIGS. 14-15. Holder 30 was previously described with referenceto FIGS. 3-4. In this embodiment, holder 30 is positionable on railassembly 400 rather than being rotatably mounted to plate 1 usingmounting arm 42 as in the previous embodiment.

Rail assembly 400 includes a carriage 410 that is slidably mounted torail 420 using structures and techniques known to those of skill in theart. Holder 30 is attached to carriage 410 thereby allowing holder 30 tobe positioned along rail 420 throughout a plurality of positionsincluding a loading position (FIG. 15) and an unloading position (FIG.16). Holder 30 and rail assembly 400 are adapted for use with any of theembodiments disclosed herein, i.e. suture winding device 100 is shown inFIGS. 15-16 for illustrative purposes only.

As suture 16 is wound onto suture winding device 100, as previouslyshown and described, carriage 410 and holder 30 move along rail 420 fromthe loading position to the unloading position. Movement of carriage 410is coordinated and synchronized with the rotation of suture windingdevice 100 such that the desired amount of tension is maintained onsuture 16 during the winding process. After the desired amount of suture16 is wound onto suture winding device 100 (i.e. holder 30 is in theunloading position), suture 16 may be separated as discussed previouslywith reference to suture winding device 100.

Joinder and formation of retainer 70 is substantially similar to that ofthe previous embodiment using pressure and/or thermal energy from heatstake apparatus 110 as illustrated in FIGS. 9-11 and discussedpreviously.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplifications ofpreferred embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

1. An apparatus for winding a suture comprising: a support member; abase member attached to the support member and defining a longitudinalaxis, the base member being movable through a plurality of positions andincluding a plurality of rods such that the suture may be sequentiallydisposed about the plurality of rods as the base member is moved throughthe plurality of positions; and a holder associated with the supportmember, the holder being configured to releasably engage the suture suchthat a predetermined amount of tension may be applied thereto.
 2. Theapparatus of claim 1, wherein the holder is repositionable between afirst position and at least one subsequent position such that the suturemay be oriented with respect to the longitudinal axis of the base memberto define a desired angle therebetween.
 3. The apparatus of claim 1,wherein the plurality of rods are configured in an arcuate arrangement.4. The apparatus of claim 3, wherein the arcuate arrangement defines atleast one array.
 5. The apparatus of claim 1, wherein the base member isconfigured to receive a suture package.
 6. The apparatus of claim 5,wherein the suture package is configured to releasably receive at leastone needle, the suture extending from an end of the at least one needle.7. The apparatus of claim 6, further including a needle holder disposedbetween the first array and at least one additional array.
 8. Theapparatus of claim 7 further including a mounting member disposed atopthe base member, the needle holder being releasably engagable withmounting member.
 9. The apparatus of claim 7, wherein the needle holderincludes a plate having a plurality of buttons disposed thereon.
 10. Theapparatus of claim 9, wherein the buttons are arranged to define atleast one channel, the at least one channel being adapted to releasablyengage a needle, the suture extending from the needle.
 11. The apparatusof claim 10, wherein the plate includes a post, a needle guide, and anend member, the post and the end member being spaced apart to define asuture channel therebetween that is configured to releasably receive thesuture.
 12. A method of winding a suture comprising the steps of:providing a winding apparatus including: a support member; a base memberattached to the support member and defining a longitudinal axis, thebase member being movable through a plurality of positions and includinga plurality of rods such that the suture may be sequentially disposedabout the plurality of rods as the base member is moved through theplurality of positions; and a needle holder associated with the basemember, the needle holder being adapted to releasably receive a needle,the suture extending from the needle; positioning the needle within theneedle holder; orienting the suture about the plurality of rods;positioning a first member of a retainer package about the needle andthe suture; moving the base member through its plurality of positionssuch the suture defines a plurality of loops; positioning a secondmember of the retainer package atop the first member of the retainerpackage; and joining the first and second members of the retainerpackage.
 13. The method of claim 12, wherein the step of providing awinding apparatus includes providing a winding apparatus including aholder associated with the support member and configured to releasablyengage the suture.
 14. The method of claim 13, further including thestep of positioning the suture within the holder prior to moving thebase member through its plurality of positions.